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Arm III: Abiraterone + Prednisone + Olaparib for Metastatic Castration Resistant Prostate Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Metastatic Castration Resistant Prostate Cancer+3 MorePrednisone - Drug
Eligibility
18+
Male
What conditions do you have?
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Study Summary

This trial is testing a new cancer treatment for men with metastatic castration resistant prostate cancer. It is a 1:1:1 randomized open-label multicenter phase II study, which means that patients will be randomly assigned to one of three different treatment groups. The study will take place at multiple centers, and patients will be observed over the course of the trial.

Eligible Conditions
  • Metastatic Castration Resistant Prostate Cancer
  • Abnormal DNA Repair
  • Advanced Prostate Cancer
  • Hormone-Refractory Prostate Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

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1
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Study Objectives

1 Primary · 9 Secondary · Reporting Duration: Up to 2 years

Up to 2 years
Incidence of Adverse Events
Measurable disease response rate by RECIST
Objective Progression Free Survival (PFS)
PSA response rate
Poly[ADP-ribose] polymerase (PARP) inhibition
Qualitative toxicities
Quantitative toxicities
Rate of undetectable PSA
The post progression PFS with cross over to olaparib or abiraterone
The post progression response rate with cross over to olaparib or abiraterone

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
Autologous DC vaccine
1
RRx-001
1
Lenvatinib

Trial Design

4 Treatment Groups

Arm III: Abiraterone + Prednisone + Olaparib
1 of 4
Arm II: Olaparib
1 of 4
Olaparib
1 of 4
Arm I: Abiraterone + Prednisone
1 of 4

Active Control

70 Total Participants · 4 Treatment Groups

Primary Treatment: Arm III: Abiraterone + Prednisone + Olaparib · No Placebo Group · Phase 2

Arm III: Abiraterone + Prednisone + OlaparibActiveComparator Group · 3 Interventions: Prednisone, Olaparib, Abiraterone Acetate · Intervention Types: Drug, Drug, Drug
Arm II: Olaparib
Drug
ActiveComparator Group · 1 Intervention: Olaparib · Intervention Types: Drug
Olaparib
Drug
ActiveComparator Group · 1 Intervention: Olaparib · Intervention Types: Drug
Arm I: Abiraterone + PrednisoneActiveComparator Group · 2 Interventions: Prednisone, Abiraterone Acetate · Intervention Types: Drug, Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years

Who is running the clinical trial?

AstraZenecaIndustry Sponsor
3,993 Previous Clinical Trials
247,423,592 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,083 Previous Clinical Trials
41,141,488 Total Patients Enrolled
Northwestern UniversityLead Sponsor
1,455 Previous Clinical Trials
789,624 Total Patients Enrolled
Maha Hussain, MD, FACP, FASCOPrincipal Investigator - Northwestern University
Jesse Brown VA Medical Center- Lakeside Clinic-CBOC, Northwestern Memorial Hospital
University Of Baghdad (Medical School)
Wayne St Univ-Detroit M C (Residency)
1 Previous Clinical Trials
72 Total Patients Enrolled

Eligibility Criteria

Age 18+ · Male Participants · 10 Total Inclusion Criteria

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References

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